Provention Bio Initiates Pivotal Study in Patients with Recent Onset Type 1 Diabetes

Provention Bio, Inc., a clinical-stage company dedicated to intercepting and preventing immune-mediated diseases, today announced that it has dosed the first patient in its Phase 3 PROTECT clinical trial of PRV-031 (teplizumab) in patients with recent onset Type 1 diabetes.

PRV-031 or teplizumab is an anti-CD3 monoclonal antibody in development for the interception of Type 1 diabetes.

“Teplizumab has the potential to be the first ever disease-modifying therapy in Type 1 diabetes, and the first drug class approved for Type 1 diabetes since the introduction of insulin,” said Dr. Kevan Herold, professor of immunobiology and Medicine at Yale University.

He added that data from prior clinical studies have indicated the potential of teplizumab to preserve functional beta cell mass, thereby conserving natural insulin production and reducing the need for insulin therapy.

“Teplizumab may, therefore, offer a much-needed improvement over currently approved treatment options for Type 1 diabetes,” Herold added. “I commend the patients, the Provention team, and my fellow clinicians for undertaking this study and look forward to further exploring its potential impact in newly-diagnosed T1D patients.”

The PROTECT study is designed to confirm the effect of PRV-031 (teplizumab) to slow the loss of insulin-producing beta cells and preserve beta cell function, as measured by C-peptide, in children and adolescents 8-17 years old who have been diagnosed with T1D in the previous six weeks and with pre-specified beta cell reserve at study entry.

“The initiation of the PROTECT study represents a significant milestone in our efforts to develop agents that intercept or prevent immune-mediated diseases,” stated Ashleigh Palmer, CEO of Provention Bio. “If successful, this pivotal Phase 3 trial could serve as the basis for a Biologics License Application (BLA) for PRV-031 (teplizumab), providing a therapeutic option that could transform the therapeutic landscape for T1D.”

About the Trial

The global PROTECT (PROvention T1D trial Evaluating C-peptide with Teplizumab) Phase 3 clinical trial is a randomized, double‑blind, placebo-controlled, multicenter trial that is expected to enroll approximately 300 patients ages 8-17 with recent onset T1D at approximately 80 centers worldwide.

The patients will be randomized 2:1 to either two 12-day cycles, six months apart, of intravenous PRV-031 (teplizumab) or placebo.

The primary efficacy endpoint is C-peptide change. Secondary endpoints include insulin use, HbA1c, hypoglycemic episodes, and safety. Provention expects to complete enrollment in the trial by the end of 2020.

Additional information is available at clinicaltrials.gov.